Associate Director, Clinical Science (Autoimmune)

Introduction:Xencor is a public clinical-stage biopharmaceutical company located in the Los Angeles area (Pasadena) and in San Diego. Our focus is developing high-potential XmAb bispecific T-cell engagers and additional engineered drug candidates that leverage our differentiated technology platforms and we are advancing our pipeline toward clinical proof-of-concept decisions. Our goal is to create high-impact therapeutics for patients with cancer and other serious diseases. More than 20 XmAb drug candidates engineered with our technology are in clinical development and three XmAb medicines have been marketed by partners. For more information please visit . We have an excellent opportunity for an Associate Director Clinical Science (Autoimmune) to join our is a hybrid or remote position. Hybrid would be based out of our San Diego or Pasadena CA : Responsible for facilitating successful and timely initiation and completion of the Companys clinical development programs in Inflammatory Bowel Disease (IBD) and other autoimmune programs by executing and monitoring medical aspects of selected global clinical trials. This role will support the design execution monitoring and interpretation of randomized placebo-controlled clinical trials in IBD as well as studies in healthy Responsibilities:Creates required clinical trial documents including clinical protocols investigator brochures DSURs and clinical modules of the IND (in concert with Study Medical Directors) Works closely with Clinical Operations to execute the clinical trial with high quality and according to timelinesPerforms ongoing review of clinical data query generation/resolution and data analysis including review of draft listings to support data cleaning and interpretationProvides scientific expertise to Clinical Operations by responding to questions and/or by clarifying issues arising during study conductProvides internal safety monitoring for clinical trials in collaboration with the Study Medical DirectorProvides medical input for the clinical database build CRFs monitoring plan data management plan safety monitoring plan and statistical analysis planDevelops and maintains relationships with clinical trial investigators and therapeutic area key opinion leaders Leads review of study data (e.g. tables listings and figures and emerging bioanalytical data) and develops CSRs clinical presentations and publicationsSupports other members of Clinical Development and Regulatory Affairs departments as requiredParticipates as a standing member of multidiscipline Project TeamsAdheres to all department and company-wide policies regarding conduct performance and proceduresPerforms other duties as requires a BS degree in life sciences; PhD RN PharmD or MS preferred and a minimum of 10 years of directly relevant pharmaceutical industry experience in clinical development and a minimum of 2 years experience of focus in assigned therapeutic area. Experience as a clinical scientist responsible for data review safety monitoring protocol development supporting data analyses interpretation and publications also required as well as clinical research experience in IBD on randomized placebo-controlled experience with translational medicine/early phase clinical trials monoclonal antibody biologics/immunotherapy and relevant tasks throughout the entire study life cycle from study concept to database lock and CSR is also requires:Strong initiative motivation organization and hands on approach with outstanding attention-to-detailExpertise in analysis and interpretation of emerging clinical data including use of software packages to analyze data (e.g. pivot tables) and EDC: MS Office Suite Visio GraphPad Prism Spotfire Medidata RAVE Inform etc. Ability to work independently and prioritize multiple tasks and goals to ensure timely on-target and within-budget accomplishmentsExcellent written and oral communication skills and interpersonal skillsAbility to adjust style/contents to suit the audience/purpose Self-starter highly motived highly organized and hands on with outstanding attention-to-detailAbility to demonstrate competencies applicable for job based on Xencors Leadership Competency ModelOccasional travel may be required including travel between Xencors Pasadena and San Diego offices. Work for this position is generally performed at Xencors worksite and requires full-time commitment. Expected Base Salary Range: $170500 - $208500The actual salary will be based on the selected candidates qualifications including skills competencies education and offers a competitive total rewards package including 401k match healthcare coverage ESPP and a broad range of other addition this position will be eligible for an annual bonus and equity grant. For more information please see with Disabilities Act (ADA) StatementThe Company will provide reasonable accommodations (such as a qualified sign language interpreter or other personal assistance) with the application process upon your request as required to comply with applicable laws. If you have a disability and require assistance in this application process please contact perform this job successfully an individual must be able to perform each essential duty satisfactorily. Reasonable Accommodations may be made to enable qualified individuals with disabilities to perform the essential Employment Opportunity (EEO) StatementThe Company is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to age race color religion sex sexual orientation gender or gender identity national origin disability status protected veteran status or any other characteristic protected by state or federal does not accept profiles or resumes from recruiting vendors without a binding written agreement. Any unsolicited submission of services and or resumes in no way creates an obligation or duty by Xencor implied or otherwise.